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Completed

NCT Number: NCT00791388

Multiple Rising Oral Dose Study of PG 760564 Administered Twice Daily to Healthy Male/Female Volunteers for 14 Days

This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses).

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stuart I Harris, MD, PhD

Miami, Florida, 33126, United States

About this study

This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses). The study is a multiple rising dose (MRD) study of active drug vs. placebo.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy males and surgically sterile or post-menopausal (last menstrual period > 1 year at the time of enrollment) healthy females, 18-45 years of age, inclusive, at screening;
  • Who have not used tobacco or nicotine-containing products within the past 3 months;
  • Willing to abstain from caffeine or xanthine-containing beverages, including coffee and tea, chocolate, alcohol, grapefruit juice, and Seville oranges, from 24 hours before admission and for the duration of the study;
  • Who have a body mass index (BMI) between 18 and 32 kg/m2.

Exclusion criteria

  • History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;
  • History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding;
  • History of autoimmune disease;
  • History of immunodeficiency or of unusual susceptibility to infectious diseases;
  • History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with human immunodeficiency virus (HIV);
  • Any history of hypersensitivity or clinically significant allergy to any drug;
  • Personal or family history of prolonged QT syndrome or any cardiac conduction abnormality;
  • Family history of sudden death;
  • History of uveitis or inflammatory ocular disease

Treatment and study plan

Placebo

Drug

oral capsule, 2x/day for 14 days

PG-760564

Drug

oral capsule, 50 mg, 2x/day for 14 days

Primary outcomes

  1. AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14

    Time frame: 14 days

    the area under the plasma concentration-time curve over a dosing interval (τ = 12 hours) on Day 14 of Multiple Dose Oral Administration of PG-760564 Given Every 12 Hours

  2. Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14

    Time frame: 12 hours on Day 14

    Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14

  3. Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14

    Time frame: 12 Hours on Day 14

    the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14

  4. t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14

    Time frame: over a Dosing Interval (τ = 12 Hours) on Day 14

    t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses).

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 14, 2008
Registry last updated
Nov 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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